Stockwinners Market Radar for May 13, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:24 EDT Exelixis to present ph. 1b trial results for cabozantinib+atezolizumab as ASCO - Exelixis announced phase 1b clinical trial results for the combination of cabozantinib, or CABOMETYX, and atezolizumab, or TECENTRIQ, in patients with locally advanced or metastatic solid tumors. The data from three expansion cohorts of the COSMIC-021 trial will be presented during the 2020 American Society of Clinical Oncology Virtual Scientific Program, or ASCO20. Results from the non-small cell lung cancer and the metastatic castration-resistant prostate cancer cohorts will be presented as posters, and results from the urothelial carcinoma (UC) cohort will be presented as a poster discussion. Initial results from the NSCLC expansion cohort will be presented by Joel Neal, M.D., Ph.D., Associate Professor of Medicine - Oncology at the Stanford University School of Medicine, one of the lead trial investigators. The analysis included 30 patients who had received prior therapy with immune checkpoint inhibitors, and 87% of patients had received prior chemotherapy. Fifty percent of patients received the cabozantinib and atezolizumab combination as their second line of therapy and 50% as their third line of therapy. At the time of enrollment in the study, the best response to prior immune checkpoint inhibitor therapy was a partial response in 3 (10%) patients, stable disease in 7 (23%) patients, progressive disease in 14 (47%) patients and unknown in 5 (17%) patients.

20:13 EDT Quidel chairman sells 5K shares of common stock - In a regulatory filing, Quidel disclosed that its chairman Ken Buechler sold 5K shares of common stock on May 11th in a transaction totaling $1.0M.

19:31 EDT SPDR Gold Shares holdings rise to 1,092.14MT from 1,083.66MT - This is the highest level of holdings since April of 2013.

18:26 EDT Cisco CEO: Webex has three times the volume it had in February - In an interview on CNBC's Mad Money, Chuck Robbins said Cisco built Webex with security at its core. Going forward, he thinks the workplace will be a hybrid model of home/office. He expects change in the way companies think about talent since they can now hire anywhere without regard to location.

18:01 EDT CoStar Group to acquire Ten-X Commercial for $190M in cash - CoStar Group announced that it plans to acquire Ten-X for $190 million in cash. Ten-X was launched in 2009 with the goal of providing a digital transaction platform for effectively liquidating the large volume of distressed commercial real estate assets that came on the market during the Great Recession. Ten-X has since become a "leading, best-in-class platform for digital commercial real estate transactions with close to $24 billion dollars of sales successfully executed on the platform. The Ten-X platform has transacted approximately $7 billion in retail properties, $6 billion in office properties, $4 billion in multifamily properties, $3 billion in hotel properties, and billions in value in other commercial property types. While Ten-X initially focused on distressed assets, non-distressed sellers and brokerage firms have increasingly come to rely on Ten-X to facilitate faster execution to transact properties."

17:54 EDT First Majestic initiates NAFTA arbitration process against Mexico - First Majestic Silver announced that the Mexican tax authority, the Servicio de Administracion Tributaria, has by its various actions "exhibited a total disregard for the applicable provisions of three separate double taxation treaties that it has entered into with Canada, Barbados and Luxembourg, which are relevant to First Majestic and its subsidiaries." Under these circumstances, and in order to formally require the Government of Mexico to address the "unlawful and unwarranted conduct of SAT for which it is responsible under international law," the company said it has taken steps to serve the Government of Mexico with a Notice of Intent to Submit a Claim under the provisions of Chapter 11 of North American Free Trade Agreement. The service of this Notice by the Company on the Government of Mexico initiates a 90-day process for the Government of Mexico to enter into good faith and amicable negotiations with the Company to resolve the current dispute between the Company and the Government of Mexico. "The Company has deep roots in the social fabric of Mexico and values its relationships in Mexico with its various business partners and with various levels of government in Mexico. It has been recognized as a "Socially Responsible Company" by the Centro Mexicano para la Filantropria (CEMEFI) for twelve consecutive years starting in 2008 until the present," the company said. "Furthermore, it has a track record of making substantial capital investments and social programs in Mexico and has plans to continue to make such further investments. The Company has invested in excess of $2.0 billion in Mexico since 2003 and has approximately 4,700 direct employees and supplies approximately 20,000 indirect jobs spread among eight states within Mexico. The Company has regretfully had to take this step of providing a Notice of Intent to Submit a Claim to Mexico so as to prevent further harm to the Company, its investments in Mexico, and to protect the health and welfare of its workforce."

17:48 EDT T. Rowe Price reports 16% stake in Ranger Energy - T. Rowe Price intends to continue engaging in "amicable discussions" with the Offering Parties and Ranger Energy. The stake reported in a company 13D filing allows for activism.

17:41 EDT Newmont to begin ramping up operations at Penasquito mine, Mexico - Newmont expects to begin safely ramping up operations at Penasquito in Mexico on May 18 following the government's designation of mining as an essential activity. The start-up of Penasquito is expected to take roughly two weeks to reach stable production levels. On April 22, Penasquito reached a definitive agreement with the San Juan de Cedros community in Zacatecas, Mexico on land use, water availability, infrastructure and social investments. This includes access to 10,000 hectares for exploration and operational purposes, and resolves all outstanding issues with the community. The agreement was reached with the support of Mexico's Ministry of Interior and representatives of the State of Zacatecas and was signed by elected representatives of the Cedros community. The agreement is expected to be ratified in a General Assembly once COVID-19 restrictions on gatherings are lifted by the government. The agreement expressly states that any future disputes will be resolved through dialogue and free of blockades. Newmont committed to paying all of its employees through the end of June to provide them certainty even if they are unable to work as a result of Coronavirus-related disruptions.

17:39 EDT Trade Desk's Paley sells 2,500 class A common shares - In a regulatory filing, Trade Desk director Eric B. Paley disclosed the sale of 2,500 class A common shares of the company on May 11 at a price of $305.59 per share.

17:32 EDT G1 Therapeutics to present data showing benefits of Trilaciclib in SCLC - G1 Therapeutics announced that data across three randomized, double-blind, placebo-controlled Phase 2 trials of the investigational therapy trilaciclib in small cell lung cancer will be presented on May 29 at the ASCO20 Virtual Scientific Program of the American Society of Clinical Oncology. In these trials, trilaciclib was administered prior to chemotherapy treatment and significantly reduced rates of myelosuppression and the need for related supportive care interventions compared with patients receiving chemotherapy treatment alone. In addition, two abstracts on the real-world burden of chemotherapy-induced myelosuppression will be published. Myelosuppression is the result of damage to bone marrow cells, and is one of the most common side effects of chemotherapy. Myelosuppression often requires the administration of rescue interventions such as growth factors and blood or platelet transfusions, and may also result in chemotherapy dose delays and reductions. Immune cell damage may decrease the ability of the immune system to fight the cancer, as well as infection. Trilaciclib is a first-in-class investigational therapy designed to preserve bone marrow and immune system function during chemotherapy and improve patient outcomes. The company plans to complete an NDA submission for trilaciclib for myelopreservation in SCLC in 2Q20. Trilaciclib has been assigned Breakthrough Therapy Designation by the FDA.

17:31 EDT VSE Corporation wins $44M in task, delivery order awards with Pentagon - VSE Corporation announced approximately $44M in task and delivery order awards with the United States Department of Defense, with work expected to begin in the second quarter of 2020. These awards include the following: A 39-month task order for new work under the Contractor Field Team program to provide flight line operations and aircraft maintenance and maintenance support to the Commander, Naval Air Forces Atlantic Fleet Replacement Squadron at Naval Air Station Jacksonville, Florida for Boeing P-8 Poseidon and Lockheed P-3 Orion aircraft; Multiple delivery orders to provide services under VSE's Foreign Military Sales contract with the Naval Sea Systems Command International Fleet Support Program Office. Under these delivery orders, VSE will provide maritime program support including logistics, planning, maintenance, training and engineering support to allied countries of the United States. "During the last 60 days, VSE announced more than $160 million in new contract awards with government customers," stated John Cuomo, President and CEO of VSE Corporation. "We remain focused on growing our Federal & Defense segment backlog through an expansion of VSE's core contracting and capability solutions, while growing with both new and existing customers. We look forward to furthering our support of NAVSEA and our allied foreign navies, and expanding our work under the CFT program at Naval Air Station Jacksonville."

17:27 EDT Discover postpones EMV fraud liability shift for automated fuel dispensers - In light of current economic and operational challenges merchants are facing, Discover is extending the EMV fraud liability shift effective date from October 16, 2020 to April 16, 2021, for contact chip transactions at automated fuel dispensers. The new date gives petroleum merchants more flexibility on installing new systems as many are dealing with economic and logistical challenges limiting their ability to make changes at their pumps due to the COVID-19 pandemic. "With the current pandemic impacting merchants around the country, we looked at our mission to be a good partner, and believe that moving this date will ease the concerns for gas stations as they look to update their automated fuel dispensers," said Andrew Hopkins, senior vice president of global products and pricing at Discover. "EMV has significantly reduced counterfeit fraud and we encourage our merchants to continue their efforts to migrate their fuel dispensers to EMV."

17:27 EDT Black Hills reaffirms guidance range issued on May 5 - Black Hills announced that members of its senior management team will visit with investors May 14 during the Credit Suisse 2020 Utilities, Power & Clean Tech Virtual Conference and May 18 and 19 during the virtually hosted American Gas Association Financial Forum. Management reaffirms its guidance range most recently issued on May 5, and will be available to discuss guidance, its response to the COVID-19 pandemic and related impacts on the company's business.

17:23 EDT Boeing awarded $1.97B Navy contract for SLAM ER missiles - Boeing was awarded a $1.97B firm-fixed-price contract to provide non-recurring engineering associated with the stand-off land attack missile - expanded response, or SLAM ER, obsolescence redesign effort as well as the production and delivery of 650 SLAM ER missiles in support of the government of Saudi Arabia. Work is expected to be complete by December 2028. Foreign Military Sales funds in the amount of $1.97B will be obligated at time of award, none of which will expire at the end of the current fiscal year. This contract was not competitively procured pursuant to Federal Acquisition Regulation 6.302-4. The Naval Air Systems Command is the contracting activity.

17:21 EDT Xencor reports initial dose escalation in ph1 study of XmAb20717 - Xencor reported initial dose-escalation data from the Phase 1 study evaluating XmAb20717, a PD-1 x CTLA-4 bispecific antibody and Xencor's first tumor microenvironment activator, in patients with advanced solid tumors. The American Society of Clinical Oncology has published an abstract with initial clinical data from the study on its website today. The Phase 1 study is currently enrolling patients with advanced non-small cell lung cancer, renal cell carcinoma, prostate cancer and other cancers without approved checkpoint therapies to expansion cohorts, as well as enrolling patients in additional dose-escalation cohorts. An expansion cohort for patients with melanoma is fully enrolled.

17:19 EDT Fiat Chrysler up almost 4% after deciding not to distribute dividend - Shares of Fiat Chrysler are up 3.6% or 28c to $8.17 per share in after hours trading after saying the company decided not to distribute an ordinary dividend in 2020 related to fiscal year 2019, in light of the impact from the current COVID-19 crisis.

17:15 EDT Bluebird Bio, Bristol-Myers to update results from KarMMa Study of Ide-cel - Bristol Myers Squibb (BMY) and bluebird bio (BLUE) announced updated results from the pivotal, Phase 2 KarMMa study evaluating the efficacy and safety of the companies' investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor CART cell immunotherapy, idecabtagene vicleucel, in patients with relapsed and refractory multiple myeloma. These data will be shared in an oral presentation at the American Society of Clinical Oncology 2020, ASCO, Virtual Scientific Program on May 29.. In the study, 128 patients with heavily pretreated relapsed and refractory multiple myeloma who were exposed to at least three prior therapies and were refractory to their last regimen per the International Myeloma Working Group (IMWG) definition (no response to therapy or disease progressed within 60 days) were treated with ide-cel across target dose levels of 150-450 x 106 CAR+ T cells. Patients had a median of six prior regimens; 84% were refractory to all three classes of commonly used treatments including an immunomodulatory (IMiD) agent, a proteasome inhibitor (PI) and an anti-CD38 antibody, and 94% were refractory to anti-CD38 antibodies. Median duration of follow-up was 13.3 months.

17:11 EDT MacroGenics 'encouraged' by early demonstration activity of MGD013 - MacroGenics announced preliminary results from two of its investigational pipeline molecules. Data covering safety and preliminary anti-tumor activity from the Phase 1 dose escalation and expansion clinical trial of MGD013, a bispecific, tetravalent DART molecule binding PD-1 and LAG-3, and the Phase 1 dose expansion study of MGC018, an antibody-drug conjugate targeting B7-H3, will be presented at the American Society of Clinical Oncology upcoming ASCO20 Virtual Scientific Program to be held May 29-31, 2020. "We are encouraged by the early demonstration of activity of MGD013, our PD-1 x LAG-3 DART molecule, particularly in combination with margetuximab, our investigational Fc-engineered monoclonal antibody targeting HER-2, where preliminary observations in a Phase 1 trial suggest a response in approximately 40% of late-stage HER-2-positive tumors that compares favorably to low response rates for HER-2-directed agents and checkpoint blockade reported historically. Our rationale for combining MGD013 and margetuximab is based on early scientific insights that antibody Fc-engineering could potentially activate immune effector cells, resulting in upregulation of checkpoint molecules, such as LAG-3, PD-1 and PD-L1, which could be targeted for blockade by bispecific DART molecules like MGD013," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Separately, we are also very encouraged by early results from an ongoing Phase 1 study of MGC018, an ADC directed against B7-H3, a molecule highly expressed on solid tumors and associated with poor clinical outcome. In this dose-escalation study, we have observed preliminary signals of anti-tumor effects, including prostate-specific antigen, or PSA, reductions of 50% or more in five of seven patients with late-stage prostate cancer."

17:08 EDT Bristol-Myers ph.3 data of Opdivo+Yervoy show meaningful NSCLC survival benefit - Bristol Myers announced the first presentation of results from the Phase 3 CheckMate -9LA trial, which demonstrated a statistically significant and clinically meaningful survival benefit with Opdivo plus Yervoy, given concomitantly with two cycles of chemotherapy, for the first-line treatment of metastatic non-small cell lung cancer, or NSCLC. The study met both its primary and key secondary endpoints, demonstrating superior overall survival, progression-free survival and overall response rate for the dual immunotherapy plus chemotherapy combination versus chemotherapy alone. At a prespecified interim analysis for the primary endpoint of OS, Opdivo plus Yervoy combined with two cycles of chemotherapy reduced the risk of death by 31% compared to chemotherapy alone at a minimum follow-up of 8.1 months. Additionally, with longer follow-up , the combination continued to show sustained OS improvements over chemotherapy alone (median OS of 15.6 months versus 10.9 months, respectively. The clinical benefit was observed across all efficacy measures in key population subgroups, including by PD-L1 expression and tumor histology. With a minimum follow-up of 12.7 months, Opdivo plus Yervoy with limited chemotherapy improved OS regardless of PD-L1 expression levels, reducing the risk of death by 38% in patients with PD-L1 less than1% and by 36% in patients with PD-L1 greater than or equal to 1%. In addition, the dual immunotherapy and chemotherapy combination demonstrated a one-year PFS rate of 33% versus 18% for chemotherapy, and an ORR of 38% compared to 25% with chemotherapy alone.

17:05 EDT iCAD presents new data for Xoft Brain IORT at ASCO - iCAD announced positive new clinical data supporting the Xoft Axxent Electronic Brachytherapy, eBx, System for the treatment of glioblastoma multiforme,GBM, will be presented at the American Society of Clinical Oncology, ASCO Virtual Scientific Program, which will take place May 29-31. "This represents a significant milestone for the company, as it further validates Xoft intraoperative radiation therapy in certain types of brain tumors and demonstrates the impact that this unique technology offers," according to Michael Klein, Chairman and CEO of iCAD. "GBM is the most common and aggressive type of malignant primary brain tumor, with a median survival of 10-12 months.1,2 With almost 297,000 cases of brain and nervous system tumors diagnosed worldwide per year,3 this exciting new application for the Xoft System could substantially expand our addressable market, but more importantly, it has the potential to extend patients' lives."

17:04 EDT ImmunoGen reports initial data from FORWARD II study - ImmunoGen announced initial data from the FORWARD II study evaluating mirvetuximab soravtansine in combination with Avastin in patients with medium and high folate receptor alpha (FRalpha)-expressing recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate. These findings will be highlighted in an oral presentation at the American Society of Clinical Oncology 2020 Virtual Scientific Program on May 29, 2020. Three "trial in progress" posters will also be presented during the meeting. "With the benefit of the clinical profile demonstrated by mirvetuximab monotherapy, we have pursued a development strategy to establish mirvetuximab as the agent of choice in combination regimens to treat expanded populations of patients with recurrent ovarian cancer. To this end, we are encouraged by the compelling anti-tumor activity and favorable tolerability observed with the combination of mirvetuximab plus bevacizumab in patients for whom a non-platinum based regimen is appropriate," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "These findings show greater depth and duration of tumor reduction in women whose tumors express high levels of FRalpha, regardless of platinum status, reinforcing the potential of this doublet in these patients. As these data mature, we look forward to further evaluating this combination in the recurrent ovarian cancer setting." This cohort enrolled 60 patients with FRalpha-positive recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate, with a median age of 60 years and a median number of 2 prior lines of therapy. The combination of mirvetuximab soravtansine with bevacizumab in this cohort demonstrates encouraging anti-tumor activity with a favorable tolerability profile, particularly among the subset of patients with high levels of FRalpha expression. Key findings include: In the overall patient population, objective responses were seen in 26 patients and the confirmed overall response rate was 43%; In patients with high FRalpha expression, the confirmed ORR was 61%, with an ORR of at least 50% in each of the platinum-resistant and platinum-sensitive subgroups; With many patients remaining on study, the duration of response and progression free survival data are immature; Te adverse events observed with the doublet were as expected based on the side effect profiles of each agent. The most common treatment-related low grade AEs were diarrhea, blurred vision, nausea, and fatigue; grade 3+ AEs were infrequent, with the most common being hypertension and neutropenia.

17:00 EDT Hexo receives NYSE listing notification - HEXO Corp. announced that it received notification from the New York Stock Exchange on April 7, 2020 that the Company was no longer in compliance with the NYSE's $1.00 share price continued listing standard as a result of the average closing price of its common shares on the NYSE falling below $1.00 for a consecutive 30 trading-day period. The issuance of the notification was not discretionary and is sent automatically when a listed company's share price falls below the Price Listing Standard. Under the NYSE's rules, the Company can regain compliance with the Price Listing Standard and avoid delisting if, within six months from the date of the NYSE notification, its common shares have a closing price on the last trading day of any calendar month and a concurrent 30 trading day average closing price of at least $1.00 per share. If the Company has not regained compliance by the end of this six month cure period, the NYSE will commence suspension and delisting procedures. In response to the COVID-19 outbreak, the NYSE made a rule filing with the SEC which became effective on April 21, 2020 for relief on the Price Listing Standard which provides for an extension of the cure period until June 30, 2020. As a result of this ruling filing, the Company currently has until December 16, 2020 to restore compliance with the Price Listing Standard. The Company expects to restore compliance with the Price Listing Standard, and to continue to maintain access to a broad range of investors, equity capital and trading liquidity through its NYSE listing. The Company is considering options to regain compliance, which may include a share consolidation, if necessary. The Common Shares will continue to be listed and traded on the NYSE during the applicable cure period, subject to continued compliance with the NYSE's other continued listing standards, under the symbol "HEXO", but the NYSE has assigned a ".BC" indicator to the symbol to denote that the Company is below the NYSE's Price Listing Standard. This indicator will be removed at such time as the Company is deemed compliant with the NYSE's Price Listing Standard.

16:59 EDT SmileDirectClub says deferral requests are far below those seen by other lenders - Says revenue increase was driven primarily by a 12% increase in aligner shipments. Says adjusted for the impact of COVID, revenue would have been over $235M. Says increased reserves by approximately $12M given the uncertainty of its economic outlook. Says expects SmilePay to continue to perform well. Says has seen only 1.7% of customers requesting a payment deferral, far below the 4%-5% deferral requests you see other lenders facing. Says the company is a telehealth business. Says has $420M of cash on its balance sheet. Says over the course of Q1, saw drastic declines in marketing and selling as a percent of revenue. Comments taken from Q1 investor presentation slides and earnings conference call.

16:50 EDT bebe stores reduces dividend to 6c from 17c amid Covid-19 pandemic - bebe stores announced that its Board of Directors declared a quarterly cash dividend of 6c per share of the Company's common stock payable June 10, 2020, to shareholders of record as of May 28, 2020. The dividend was reduced from the previous quarter's dividend of 17c per share due to disruption in the retail sales channels caused by Covid-19, which reduced cash flow to licensees of the Company's joint ventures. The Board of Directors remains committed in principle to paying shareholders substantially all of the Company's free cash flow via dividends and expects to increase the quarterly cash dividend after the adverse business effects of the Covid-19 virus subside.

16:46 EDT Accelerate Diagnostics director Jack Shuler buys 20K shares of company stock - Accelerate Diagnostics director Jack Shuler bought 20,000 shares at an average price of $9.99 for a total transaction value of $199,800.

16:33 EDT Fiat Chrysler, Peugeot will not distribute dividend in FY20 - The board of directors of Fiat Chrysler Automobiles N.V. (FCAU) and the managing board of Peugeot S.A. (PUGOY) each decided not to distribute an ordinary dividend in 2020 related to fiscal year 2019, in light of the impact from the current COVID-19 crisis. FCA and Groupe PSA confirm that preparations for the 50/50 merger of their businesses announced in December 2019 are advancing well, including with respect to antitrust and other regulatory filings. Completion of the proposed combination is expected on schedule, before end of Q1 2021, subject to customary closing conditions.

16:30 EDT Immunic up 45% afterhours following ph.2 trial of IMU-838 approval in Germany

16:22 EDT Penske Automotive suspends quarterly dividend - Penske Automotive Group announced that its Board of Directors has suspended its cash dividend. The company previously paid a quarterly dividend of 42c per share to shareholders on March 3. The company estimates that the suspension of the dividend will preserve approximately $34M in cash during the second quarter. Commenting on the announcement, Chair Roger Penske said, "The decision to suspend the quarterly dividend is consistent with the other measures the company has implemented to mitigate the impact of Covid-19, including a hiring freeze, the deferral of approximately $150 million in capital expenditures, and the furloughing of 57% of its worldwide workforce, among others."

16:22 EDT Penske Automotive suspends quarterly dividend - Penske Automotive Group announced that its Board of Directors has suspended its cash dividend. The company previously paid a quarterly dividend of 42c per share to shareholders on March 3. The company estimates that the suspension of the dividend will preserve approximately $34M in cash during the second quarter. Commenting on the announcement, Chair Roger Penske said, "The decision to suspend the quarterly dividend is consistent with the other measures the company has implemented to mitigate the impact of Covid-19, including a hiring freeze, the deferral of approximately $150 million in capital expenditures, and the furloughing of 57% of its worldwide workforce, among others."

16:21 EDT 89bio announces FDA clearance of BIO89-100 IND application for SHTG

16:19 EDT Bed Bath & Beyond names Cindy Davis Chief Brand Officer, President of Decorist - Bed Bath & Beyond (BBBY) announced the appointment of Cindy Davis as Executive Vice President, Chief Brand Officer of Bed Bath & Beyond and President, Decorist, effective May 26. Davis will report directly to Mark Tritton, Bed Bath & Beyond's President & CEO. Davis will join the company from L Brands (LB), where she currently serves as EVP and Chief Digital Marketing Officer.

16:17 EDT BRP Group says balance sheet strong amid COVID-19 pandemic - "Looking ahead, our proactive efforts to strengthen our balance sheet have positioned us very well to navigate the challenges stemming from the COVID-19 pandemic," added Mr. Baldwin. "During the first quarter, we completed four Partner acquisitions, and have since completed another three Partner acquisitions, representing over $42 million in annualized revenue thus far in 2020. We continue to maintain a strong balance sheet and have ample capacity to continue prudently executing on our growth strategy. With a majority of our businesses operating in geographies that have been less impacted by COVID-19 to date and that are now starting to reopen their economies, we are cautiously optimistic that many of our Clients are beginning to see the road to recovery."

16:15 EDT PROS names Les Rechan COO - PROS announced that Les Rechan has been appointed as Chief Operating Officer - a new role to further enable the company to aggressively adapt and pursue market and customer opportunities as businesses accelerate adoption of AI-based digital selling solutions and redefine digital commerce initiatives in a post-COVID-19 era. In this new role reporting to Andres Reiner, PROS President and CEO, Rechan is now responsible for all go-to-market and customer experience and engagement functions to further scale and grow these operations globally.

16:14 EDT SmileDirectClub marketing spend was reduced by approximately 90% - Since Q1, the Company has seen robust performance in its impression kit business, despite a significant reduction in marketing spend. This demonstrates that investments in brand building and marketing efficiency have begun to pay dividends. Specifically, although marketing spend was reduced by approximately 90% over the past 60 days, kit and scan volume was down by only approximately 40%. Additionally, because the Company has very few fixed costs and the vast majority of its SmileShops around the world operate on month-to-month leases, it has been able to take decisive action, including the temporary closure of all SmileShops other than those in Hong Kong. The Company has also put in place several cost management measures, including the suspension of most of its marketing spend, to position the Company to operate cash-neutral during this period. Additionally, SmileDirectClub has entered into a new debt facility with HPS Investment Partners. After refinancing the previous debt facility, the Company will have approximately $420 million in cash on its balance sheet, giving the liquidity needed to continue its growth plans and manage potential downsides with COVID-19. This facility improves upon the limitations of the previous facility by providing a 5-year term that can be refinanced after one year, and an 85% advance rate on the Company's receivables. The agreement also funds both domestic and international receivables. As the Company considered financing alternatives, given the leadership team's conviction in the long-term equity value appreciation of the business, a top priority was minimizing equity dilution, and the agreement with HPS achieves this goal. J.P. Morgan Securities LLC served as lead arranger and sole placement agent to SmileDirectClub.

16:11 EDT BioPharmX shareholders approve merger with Timber Pharmaceuticals - BioPharmX announced that all proposals related to its proposed merger with Timber Pharmaceuticals were approved by BioPharmX's stockholders at a special meeting held on May 13. The proposed merger remains subject to further customary closing conditions and regulatory approvals. BioPharmX and Timber expect the closing of the merger to occur on or about May 18. Upon closing of the transaction, the combined company will change its name to "Timber Pharmaceuticals, Inc." and it is anticipated that the shares will commence trading on the NYSE American market under the ticker symbol "TMBR." The officers and managers of Timber will assume leadership of the combined company with Michael Derby serving as Chairman and John Koconis as CEO.

16:09 EDT B Communications regains compliance with Nasdaq requirement - B Communications announced that on May 13, BCOM received a notice from Nasdaq that it has regained compliance with the $1 per share minimum bid price requirement.

16:08 EDT Cisco reports Q3 adjusted gross margin 66.6% - On a non-GAAP basis, total gross margin, product gross margin, and service gross margin were 66.6%, 65.8%, and 68.9%, respectively, as compared with 64.6%, 63.7%, and 67.3%, respectively, in the third quarter of fiscal 2019

16:06 EDT Jack in the Box suspends share repurchases, quarterly dividend - Lenny Comma, chairman and chief executive officer, said, "Our same-store sales growth during the first seven weeks of the quarter exemplified our strategy of combining compelling bundles at competitive price points with innovation, including the menu addition of Tiny Tacos. Tiny Tacos helped to re-establish our equity in Tacos while delivering a craveable product at a great price. As we navigate the COVID-19 pandemic, I am proud of the way our teams in the restaurant, our employees, our franchisees and partners have responded nimbly to the changing occasions of our consumers. We remain committed to operating our restaurants with integrity, providing great guest service, and most importantly, protecting the health and safety of our employees and guests. We are dedicated to remaining open to serve guests during this time of uncertainty. "Given this uncertainty, we are prioritizing actions to bolster liquidity in the event we encounter greater volatility to our business. Because of this, we have temporarily suspended both share repurchases and the quarterly dividend typically paid next month with the intent to re-evaluate these decisions each quarter as we gain greater clarity on any further negative impact to our business trends."

16:06 EDT Immunic's Phase 2 trial in COVID-19 approved in Germany - Immunic has received first regulatory approval from Germany's BfArM - Bundesinstitut fur Arzneimittel und Medizinprodukte - to initiate a phase 2 clinical trial of its selective oral DHODH inhibitor, IMU-838, in coronavirus disease 2019. The CALVID-1 study is a prospective, phase 2 clinical trial in approximately 230 patients with moderate COVID-19, designed to evaluate efficacy, safety and tolerability of IMU-838. Dosing of the first patient is expected to occur later this month. Top-line data is expected to be available later this year. IMU-838 had successfully demonstrated preclinical activity against severe acute respiratory syndrome coronavirus 2 - SARS-CoV-2 -. Specifically, IMU-838 was observed to inhibit replication of clinical isolates of SARS-CoV-2 associated with COVID-19. IMU-838 has already been tested in about 650 individuals. The aim of the CALVID-1 trial is to investigate IMU-838 as an oral treatment option for COVID-19 and to enable the use of IMU-838 as a treatment for current and potential future pandemic threats. Inclusion criteria are hospitalized adult patients with a confirmed SARS-CoV-2 infection fulfilling clinical status category 3 or 4. The primary endpoint will be the proportion of patients free of invasive ventilation throughout the entire study period. Secondary endpoints include duration of hospitalization, duration of intensive care unit treatment, 28-day all-cause mortality, time to clinical improvement and viral titer reduction. If clinical activity of IMU-838 is confirmed by the Independent Data Monitoring Committee, an expansion of this trial into a confirmatory phase 3 trial could be recommended.

16:05 EDT Ultragenx reports results from cohorts in study of DTX301 OTC gene therapy - Ultragenyx Pharmaceutica announced positive longer-term saflety and efficacy data from the first three cohorts of the ongoing Phase 1/2 study of DTX301, an investigational adeno-associated virus, AAV,gene therapy for the treatment of ornithine transcarbamylase, OTC, deficiency. Six of nine patients in the study have responded to the gene therapy (three female, three male), including all three patients in Cohort 3 who are now confirmed responders. The three previously disclosed complete responders, who have discontinued all ammonia scavengers and liberalized their diet, remain clinically and metabolically stable after longer-term follow-up. Data from the Phase 1/2 study were presented today at the American Society of Gene & Cell Therapy (ASGCT) virtual 2020 Annual Meeting. "We are seeing durable and clinically meaningful responses to DTX301. We are extremely encouraged that the patients who have stopped alternate pathway medications and liberalized dietary restrictions continue to do very well over these longer periods of time," said Eric Crombez, M.D., Chief Medical Officer of the Ultragenyx Gene Therapy development unit. "The recent data also reinforces the higher response rate seen with the Cohort 3 dose of 1x10^13 GC/kg. All three patients in Cohort 3 have responded to DTX301 and the treating physician of one of these patients reported that this is the best she has been health wise. This dose has been selected for the Phase 3 study, which is currently expected to initiate in the first half of 2021."

16:02 EDT JAKKS Pacific sees retail disruptions continuing in second half - "Looking toward the second half of the year, we expect retail disruption to continue, but to ease as the stay-at-home guidelines and orders are lifted," said CEO Stephen Berman. "Our retail POS trends were positive during the first quarter and have continued to be positive in recent weeks. We will focus on products that remain in demand even with the disruption to normal buying patterns, and we expect to benefit from pent-up demand and clean retail inventories later in the year."

15:20 EDT CommScope wins injunction, enhanced damages against Dali Wireless - CommScope secured another significant win in its litigation with Dali Wireless. A previous jury ruling determined that Dali willfully infringed five of CommScope's digital distributed antenna system patents. A Court judgment this week addressed Dali's willful infringement by granting CommScope both an injunction and enhanced damages against Dali. The Court ruled that Dali's willful infringement warranted an injunction against the Dali infringing products for the life of CommScope's asserted patents. The life of the last-to-expire of CommScope's asserted patents extends to 2026. Dali would be barred from selling its infringing tSeries and Matrix products into April of 2026. The Court also ruled that Dali's willful infringement warranted trebling the damages, increasing the damages award from $2M to $6M. All remedies addressed in the Court's judgment were stayed pending appeal. The Court's trebling of the jury award represents the maximum possible penalty under the law reserved for especially egregious infringers. The award serves an important function of discouraging further infringement. The Court found that Dali failed to investigate the asserted patents, even after it was repeatedly warned by customers and competitors that Dali's products may infringe CommScope's patent portfolio on digital DAS technology. The Court's order also allows CommScope to file its appeal on the two patents Dali asserted against CommScope's FlexWave Prism, currently discontinued, and ION-E products. The Patent Office has already found that the claims Dali asserted against the ION-E are invalid in a parallel Inter Partes Review proceeding.

15:01 EDT VMware announces intent to acquire Kubernetes security startup Octarine - VMware made two key announcements during Connect 2020, the company's annual cybersecurity user and partner conference, hosted virtually by VMware Carbon Black. The intent to acquire Octarine," whose innovative security platform for Kubernetes applications helps simplify DevSecOps and enables cloud native environments to be intrinsically secure, from development through runtime," said the company. "The creation of a Next-Gen SOC Alliance along with Splunk, IBM Security, Google Cloud's Chronicle, Exabeam, and Sumo Logic. The alliance empowers SOC teams with visibility, prevention, detection and response capabilities that can uniquely leverage the VMware fabric. Intent to Acquire Octarine to Bring Intrinsic Security to Containers & KubernetesProtecting workloads is critical to the security of applications and data inside every organization. The unique properties of the cloud mean that developers are increasingly using Kubernetes and containers to modernize applications and changing the nature of workloads that need to be secured," added the company.

14:33 EDT Google adding tab grouping enhancement to Chrome - Edward Jung UX Engineer, Chrome wrot in a blog posting: "There are two types of people in the world: tab minimalists who have just a few tabs open at a time and tab collectors who have...significantly more. For minimalists and collectors alike, we're bringing a new way to organize your tabs to Chrome: tab groups. This feature is available now in Chrome Beta. Now, with a simple right click, you can group your tabs together and label them with a custom name and color. Once the tabs are grouped together, you can move and reorder them on the tab strip. We've been testing out tab groups for several months now (as have some of you), and we're finding new ways to stay organized. Through our own usage and early user research, we've found that some people like to group their Chrome tabs by topic. For instance, it helps if you're working on several projects, or looking through multiple shopping and review sites." Reference Link

13:52 EDT CVS unit pays $15.3M civil penalty for improper opioid dispensing - United States Attorney for Colorado Jason Dunn announced that Omnicare, a subsidiary of CVS Health, has agreed to pay the United States a $15.3M civil penalty to resolve allegations that it violated federal law by allowing opioids and other controlled substances to be dispensed without a valid prescription. The United States alleged that Omnicare violated the federal Controlled Substances Act in its handling of emergency prescriptions, its controls over the emergency kits, and its processing of written prescriptions. Reference Link

13:41 EDT North American rail traffic dropped 20.5% in week ended May 9 - The Association of American Railroads, AAR, reported U.S. rail traffic for the week ending May 9. For this week, total U.S. weekly rail traffic was 412,549 carloads and intermodal units, down 22.1% compared with the same week last year. Total carloads for the week ending May 9 were 185,144 carloads, down 28.4% compared with the same week in 2019, while U.S. weekly intermodal volume was 227,405 containers and trailers, down 16 percent compared to 2019. None of the 10 carload commodity groups posted an increase compared with the same week in 2019. Commodity groups that posted decreases compared with the same week in 2019 included coal, down 34,111 carloads, to 46,515; motor vehicles and parts, down 14,876 carloads, to 2,108; and metallic ores and metals, down 7,513 carloads, to 13,624. North American rail volume for the week ending May 9, 2020, on 12 reporting U.S., Canadian and Mexican railroads totaled 266,647 carloads, down 27.2% compared with the same week last year, and 309,826 intermodal units, down 13.8 percent compared with last year. Total combined weekly rail traffic in North America was 576,473 carloads and intermodal units, down 20.5% . North American rail volume for the first 19 weeks of 2020 was 11,978,186 carloads and intermodal units, down 10.4% compared with 2019. Publicly traded companies in the space include CSX (CSX), Canadian National (CNI), Canadian Pacific (CP), Genesee & Wyoming (GWR), Kansas City Southern (KSU), Norfolk Southern (NSC) and Union Pacific (UNP).[]:[https://www.aar.org/news/weekly-rail-traffic-for-the-week-ending-may-9-2020/]

13:00 EDT Axon forms partnership with British Columbia Women in Law Enforcement - Axon announced a partnership with the British Columbia Women in Law Enforcement organization. This partnership is designed to support BCWLE's purpose of uniting law enforcement members in British Columbia by encouraging members to discuss topical issues affecting women in policing, providing training for issues specifically related to women, and facilitating networking and mentoring opportunities. "BCWLE is looking forward to this new partnership with Axon," says BCWLE President, Shannon Olesen. "Axon has been a strong supporter of women in law enforcement across Canada for many years. We are excited to see what we can do together."

12:50 EDT Uber reducing maximum suggested number of passengers for UberX to 3 from 4

12:49 EDT Boyd Gaming falls 8% after S&P downgrade amid coronavirus shutdowns - Shares of Boyd Gaming are down 7.48% or $1.25 to $15.45 per share in early afternoon trading after S&P issued a negative outlook. "The negative outlook reflects Boyd's very high anticipated leverage in 2020 and the elevated degree of uncertainty in our updated base-case scenario around the extent of the pandemic and the related recession's effect on the company's performance. We could lower our ratings on Boyd if we no longer believe the coronavirus will be contained by the middle of 2020, preventing Boyd from reopening its casinos in the second half of 2020," said S&P.

12:37 EDT Online gaming giant Tencent delivers 26% revenue gain amid COVID shut down - Shares of Chinese multinational and video game company Tencent (TCEHY ) are trading higher on Wednesday after reporting first quarter earnings that were ahead of Wall Street expectations. Amid a global coronovirus pandemic, homebound Chinese consumers looked to video games, which helped fuel Tencent's quarterly net profit growth of 6% from the same period last year. GAMES FUEL GROWTH: Tencent reported that Q1 profit climbed to 28.9B yuan, ahead of consensus estimates. Revenue for the quarter rose 26% to 108B yuan, also better than analysts had anticipated. EBITDA was RMB42,228M up 26% year over year. Adjusted EBITDA was RMB45,190M up 27% y/y. Online game revenues grew by 31% y/y to RMB37,298M. The increase primarily reflected revenue contributions from domestic smartphone games such as Peacekeeper Elite and Honour of Kings, as well as increased contributions from its overseas titles, including PUBG Mobile and Clash of Clans, partly offset by lower revenues from PC client games such as DnF, Tencent said in a statement. "As the world tackles COVID-19, our thoughts and hearts go out to all the people who are suffering from the pandemic. During this difficult period, we seek to provide online services that keep people connected, informed, productive and entertained. OUTLOOK: Tencent added: "In the first quarter of 2020, we harnessed the power of technology to enable users to stay connected, informed and entertained, to help advertisers reach target audiences effectively, and to assist enterprises in achieving service continuity. Looking forward, we expect in-game consumption activities to largely normalize as people return to work, and we see some headwinds for the online advertising industry." PRICE ACTION: Shares of Tencent Holdings are up 4.1% to $57.60 in midday trading. OTHERS TO WATCH: Activision Blizzard (ATVI), Electronic Arts (EA), GameStop (GME), Nintendo (NTDOY), Take-Two (TTWO) and Ubisoft (UBSFY),Take-Two (TTWO), Nvidia (NVDA) and AMD (AMD).

12:18 EDT Tepper sees COVID-19 vaccine in Q2 of next year 'if we're lucky' - David Tepper of Appaloosa Management is speaking on CNBC.

12:14 EDT NYC Committee passes bill to cap restaurant delivery service fees - The New York City Council's Committee on Small Business has passed a package of legislation that temporarily caps fees for restaurants charged by third-party delivery services, such as Grubhub (GRUB) and Uber Eats (UBER). This bill would restrict the fees that certain third-party food delivery services, entities that provide restaurants with online order and delivery services, may charge restaurants during states of emergency when restaurants are prohibited from offering food for consumption on-premises, plus an additional 90 days thereafter. During such time periods, third-party delivery services would be prohibited from charging more than a 15% fee per order for providing delivery services to a restaurant, and more than a 5% fee per order for all other types of charges. Violations of the prohibitions in this bill would be subject to civil penalties of up to $1000 per restaurant per day. The Corporation Counsel would be empowered to enforce the bill's provisions by instituting civil action against third-party delivery services in violation, and by conducting investigations pursuant to such civil action. Reference Link

12:14 EDT Tepper wants to be invested in banks 'at some point' - David Tepper of Appaloosa Management is speaking on CNBC. Publicly traded companies in the bank space include Bank of America (BAC), Citi (C), Goldman Sachs (GS), JPMorgan (JPM), Morgan Stanley (MS), U.S. Bancorp (USB) and Wells Fargo (WFC).

12:12 EDT Tepper says bottom may be in, but market can still fall significantly - David Tepper of Appaloosa Management is speaking on CNBC.

12:09 EDT Tepper says valuation of some smaller Nasdaq names 'nuts' - David Tepper of Appaloosa Management is speaking on CNBC.

12:07 EDT Tepper says you can make argument for bank stocks being lower - David Tepper of Appaloosa Management is speaking on CNBC. Publicly traded companies in the bank space include Bank of America (BAC), Citi (C), Goldman Sachs (GS), JPMorgan (JPM), Morgan Stanley (MS), U.S. Bancorp (USB) and Wells Fargo (WFC).

12:04 EDT Tepper says only 1999 represented more overvalued market than today - David Tepper of Appaloosa Management is speaking on CNBC.

12:03 EDT Tepper says before yesterday, market had 15% downside, 5% upside - David Tepper of Appaloosa Management is speaking on CNBC.

12:02 EDT Tepper says Fed moves, stimulus packages have moved markets higher - David Tepper of Appaloosa Management is speaking on CNBC.

12:00 EDT 8x8, Inc. falls -21.6% - 8x8, Inc. is down -21.6%, or -$4.42 to $16.00.

12:00 EDT Small Cap Bear 3x rises 10.3% - Small Cap Bear 3x is up 10.3%, or $3.64 to $39.11.

12:00 EDT United Natural Foods rises 45.8% - United Natural Foods is up 45.8%, or $7.11 to $22.62.

11:48 EDT Novo Nordisk reports STEP 4 trial achieved primary objective - Novo Nordisk announced headline results from STEP 4, the first completed phase 3a trial in the STEP program. STEP 4 is a randomized, double-blind, multicentre, placebo-controlled, withdrawal trial exploring sustained weight management with semaglutide vs placebo. The 68-week trial investigated the effect of once-weekly subcutaneous semaglutide 2.4 mg on body weight in 902 people with obesity or overweight with comorbidities. After the 20-week run-in period, the 803 people reaching the target dose of semaglutide 2.4 mg had reduced their mean body weight from 107.2 kg to 96.1 kg and were randomized to continued treatment with either once-weekly sc semaglutide 2.4 mg or placebo for 48 weeks. The trial achieved its primary objective by demonstrating that in all people randomized, continued treatment with sc semaglutide 2.4 mg for 48 weeks, after the run-in period, resulted in an additional mean weight loss of 7.9%, from a mean baseline body weight at randomization of 96.1 kg, whereas people on placebo regained 6.9% of the body weight. The treatment difference was statistically significant. People who received sc semaglutide 2.4 mg for 68 weeks - run-in period plus 48 weeks - achieved a total weight loss of 17.4%.

10:30 EDT Gol Linhas: Ops. expected to be at 12% of last year's schedule by end of May

10:29 EDT Gol Linhas maintains level of conservativeness in cash burn forecasts - GOL Linhas Aereas Inteligentes provides an Investor Update for April. As the pandemic situation develops, GOL will continue to provide monthly updates of results and liquidity to its constituents and stakeholders in the spirit of transparency. GOL made the necessary cost reductions quickly and shored up liquidity to withstand the crisis. To preserve cash, management acted on a variety of cost-saving measures, including the deferral of heavy maintenance costs and over 6,000 voluntary employee leaves of absence, or about 40% of its workforce. With limited visibility into the recovery, GOL's current planning scenario assumes (-45)% y/y 2020 capacity, including (-30)% y/y by 4Q20, but it has the flexibility to respond to prevailing demand trends. The Company is maintaining its level of conservativeness in its cash burn forecasts, which is prudent given the likely longer demand recovery curve, especially for international travel. On these conservative assumptions, the Company estimates that it has over 10 months of cash-on-hand, assuming that all financial expenses and debts are paid in full. The Company has grounded 120 aircraft since March 28 and flights in April were operated from the Guarulhos airport in Sao Paulo to all of Brazil's state capitals and the federal capital in Brasilia, which represents 7% of the April 2019 schedule. By the end of May, operations are expected to be at 12% of last year's schedule, with the planned re-opening of the bases at the Foz de Iguacu, Navegantes and Maringa airports, and the re-initiation of a limited number of flights from the Congonhas airport in Sao Paulo to the Santos Dumont and Galeao airports in Rio de Janeiro. GOL reduced its gross cash operating costs from R$9 million/day in April, and expects R$8 million/day for May.

10:14 EDT VectolQ Acquisition Corp trading resumes

10:03 EDT Rite Aid announces partnership with Instacart for delivery - Rite Aid announced a partnership with Instacart, which will allow customers to conveniently order and receive essential healthcare and grocery items delivered directly to their homes during the COVID-19 pandemic and beyond. Instacart delivery is now available from Rite Aid's more than 2,400 locations across 18 states. All Instacart orders now default to "Leave at My Door Delivery," in order to maintain social distance and allow customers to receive deliveries safely.

10:00 EDT Hudson falls -10.7% - Hudson is down -10.7%, or -58c to $4.91.

10:00 EDT 8x8, Inc. falls -15.9% - 8x8, Inc. is down -15.9%, or -$3.25 to $17.18.

10:00 EDT PGT Innovations rises 22.8% - PGT Innovations is up 22.8%, or $2.23 to $12.00.

09:57 EDT Agenus mulls options for AgenTus Therapeutics subsidiary - Agenus indicated that it is contemplating several options with regard to its AgenTus Therapeutics subsidiary. This is given its previous guidance and the advancement of AgenTus' first cell therapy candidates towards the clinic. These options include the potential spinning out of AgenTus and issuing a portion of its holdings in AgenTus to Agenus shareholders in the form of a stock dividend. Agenus expects that such a decision will be made by the end of this year.

09:50 EDT Amazon.com announces new Fire HD 8, Fire HD 8 Plus, Fire HD 8 Kids Edition - Amazon announced the next generation of its Fire HD 8 tablet lineup, designed with the entire family in mind: the all-new Fire HD 8, Fire HD 8 Plus, and Fire HD 8 Kids Edition. "The new Fire HD 8 tablets offer the features that everyone in the family wants - great content, more storage, longer battery life - at a price that is incredibly affordable," said Kevin Keith, Vice President, Amazon Devices. "We've made the all-new Fire HD 8 even better with faster performance, 32GB of internal storage, up to 12 hours of battery life, and easier charging with USB-C-all for only $89.99. For only $20 more, the Fire HD 8 Plus packs even more power with 50% more RAM, hassle-free wireless charging, and six months of Kindle Unlimited included. With access to millions of movies, TV shows, books, songs, magazines, Alexa, and more-Fire HD 8 and Fire HD 8 Plus are the perfect tablets for entertainment."

09:47 EDT Navios Maritime Partners falls -11.9% - Navios Maritime Partners is down -11.9%, or -81c to $6.01.

09:47 EDT Synnex rises 9.1% - Synnex is up 9.1%, or $7.59 to $91.24.

09:47 EDT PGT Innovations rises 18.7% - PGT Innovations is up 18.7%, or $1.83 to $11.60.

09:42 EDT McDonald's unveils additional safety measures for restaurants during COVID-19 - Joe Erlinger, President McDonald's USA, said in a statement: "As we come together again, we are prioritizing staying safely apart. We are building on the processes already in place such as wellness checks, social distancing floor stickers, protective barriers at order points, masks and gloves for employees with the addition of new procedures, and training for the reopening of dining rooms. These will serve as a set of nationwide standards for operations across all 14,000 U.S. McDonald's locations. All restaurants must implement these standards, in addition to state and local laws, before reopening a dining room. New procedures and guidelines for in-restaurant dining include: Closing some seating and tables to accommodate social distancing; More frequent cleaning of high touch surfaces, including tables; Continued care efforts, including crew members wearing masks or face coverings, and gloves, and making masks available for customers in municipalities where they are required; Keeping Play Places closed and modifying our dine-in beverage procedures to minimize contact. With adherence to these new procedures and guidance, as well as continuing to rely on guidance from CDC, state and local authorities, McDonald's, in partnership with Owner/Operators will make reopening decisions that are right for the local communities and help ensure restaurant crew and customers feel safe and welcome. As our daily routines continue to evolve, we remain committed to safely serving you and our local neighborhoods around the country. We look forward to welcoming you back into our dining rooms, when the timing is right and with these extra precautions in place." Reference Link

09:22 EDT OncoSec's Tavo granted ATMP certification in Europe for application in melanoma - OncoSec announced the European Medicines Agency issued an advanced therapy medicinal product, or ATMP, certificate for chemistry manufacturing controls data covering its lead product candidate, Tavo, for the treatment of metastatic melanoma. Following Tavo's classification as an ATMP last year, the certification procedure involved a thorough scientific evaluation over several months of CMC data for TAVO by the EMA's Committee for Advanced Therapies. After a positive opinion from CAT, EMA issued a certificate confirming that the CMC data comply with the standards that apply for evaluating the Marketing Authorization Application. The Committee for Advanced Therapies is the committee at the European Medicines Agency that is responsible for classifying and assessing the quality, safety and efficacy of advanced-therapy medicinal products and following scientific developments in the field. The ATMP designation is a classification for certain medicines for human use that are gene-, cell-, or tissue-based. The main responsibility of the CAT is to prepare a draft opinion on each ATMP application submitted to the European Medicines Agency, before the Committee for Medicinal Products for Human Use adopts a final opinion on granting a marketing authorization for the product. OncoSec has expanded its pivotal KEYNOTE-695 study of Tavo to Europe, laying the foundation for a MAA submission within the EU.

09:19 EDT Cemtrex receives VR application order from VF Corp. - Cemtrex (CETX) announced that it has received an order from VF Corporation (VFC) to build a virtual reality application. The VR application is aimed for corporate and third party use around creating better retail experiences for customers. The application also provides training solutions for VF Corp's employees and its retail partners. In the wake of COVID-19, many companies are turning to virtual reality to deliver on the needs of customers while getting around social distancing protocols. Virtual reality provides new avenues for collaboration, training, and engagement around employees that are now working from home. Additionally, VR offers companies the opportunity to reach customers at a time when almost all retail stores are shuttered with no end in sight. Many companies like VF Corp are getting out in front of the challenges stay-at-home orders have presented by investing in the latest VR technology to adapt in this rapidly changing environment. Cemtrex already has a head start in developing VR applications and has developed numerous VR applications and products for a diversified group of clients over the past two years. CemtrexLabs, a division of Cemtrex, will be delivering the application within this quarter and it will be built on Oculus Quest. The Company sees this order as a long-term opportunity to work with VF Corp to roll out cutting-edge, VR applications, that can scale across their many brands and retail touch points.

09:18 EDT Genius Brands raises equity financing to further company growth - Genius Brands International announced last week that it has completed a securities purchase agreement to raise $2.8M through the issuance of Common Stock and another securities purchase agreement signed yesterday to raise $5.4M through the issuance of Common Stock. Genius Brands intends to use the proceeds to fund additional episodes of its hit series, Rainbow Rangers, to debut on Nick Jr. in conjunction with the August 2020 launch of the toy line from Mattel, Inc. at Walmart stores. The Company will also apply the financing to fuel the growth of its newly-announced digital network for children and families, Kartoon Channel! which will launch in June 2020 with availability in over 100M U.S. television households, and 200 million mobile devices. Genius Brands has announced the series, Stan Lee's Superhero Kindergarten, which stars Arnold Schwarzenegger and will debut on Amazon Prime in 2021. The Company has partnered with China's Alibaba Group on the series and will use a portion of the proceeds to produce Stan Lee's Superhero Kindergarten, as well as to pay down debt and to provide working capital.

09:16 EDT Charles & Colvard partners with Hudson's Bay - Charles & Colvard announced its launch with Hudson's Bay. An assortment of fine jewelry featuring Moissanite by Charles & Colvard gemstones is now available to the retailer's robust digital audience on TheBay.com. The assortment now available on TheBay.com includes Moissanite by Charles & Colvard bridal and fashion rings, necklaces, bracelets and earrings in 14k white, yellow and rose gold.

09:09 EDT Domo partners with Unilever's "United for America" initiative - Domo (DOMO) announced its participation in the Unilever (UN, UL) "United for America" project as a technology partner. The initiative, which launched in March and includes a "National Day of Service" on May 21, will contribute more than $20 million worth of products, services and financial support for Americans in need. Domo is donating the use of the Domo platform and the expertise of its people to help Unilever monitor the philanthropic program's supply chain, track donations and manage and understand the effect of volunteer hours. This data will help Unilever quantify the impact of the donations that will be made during its National Day of Service and share that information with executive team members, brand managers, logistics partners, retailers and volunteers. Additionally, Domo's COVID-19 Tracker will allow Unilever to layer in, on its United for America website, up-to-date coronavirus data aggregated from organizations including the CDC, World Health Organization, Johns Hopkins University, Worldometer and other reputable sources to help people understand the changing status of the disease.

09:07 EDT Scientific Games awarded three-year contract for lottery in central Germany - Scientific Games was awarded a new, three-year contract to provide instant games to LOTTO Thuringen in central Germany. The company won the contract, which may be extended one additional year, following a competitive procurement process. The company has partnered with LOTTO Thuringen for more than two decades and currently serves all 16 state lotteries in Germany.

09:06 EDT Procter & Gamble, Cargill collaborate to develop bio-based acrylic acid - An innovation developed in the corporate R&D labs at Procter & Gamble that converts lactic acid into bio-based acrylic acid could be a helpful step to shift everyday goods to be made from annually renewable crops. P&G has granted Cargill an exclusive license that allows Cargill to further develop and commercialize this technology, so that it can ultimately be incorporated in a range of applications from superabsorbent polymers in absorbent hygiene products to thickeners in household paints and beyond. The use of bio-based acrylic acid is estimated to reduce greenhouse gas emissions and contribute to greener products for years to come. While the conversion technology is considered a breakthrough, it will take several more years of development before impacting consumer products in the marketplace.

09:02 EDT CohBar COO Jon Stern to step down - CohBar announced that Jon Stern plans to step down from his role as the company's COO, effective May 31, 2020. Since joining the company in 2012, Mr. Stern has served in various executive roles including chief strategic officer and CEO. He will remain actively involved as a member of the company's board of directors.

09:01 EDT Honeywell CEO sees recovery in quarters, not years

09:01 EDT Honeywell was 'much more challenged' in April, CEO says

09:01 EDT Honeywell CEO sees lower demand environment 'for awhile'

08:55 EDT LPL Financial to open Austin base for technology workforce - LPL Financial announced the firm is hiring for technology roles to be based at a new office location in Austin, Texas. The Austin base, part of the firm's existing 2020 technology plans, will enable greater access to a workforce that will further support the firm's continuous delivery of innovative technology solutions powering its more than 16,000 financial professionals. LPL will occupy space in a building within Paloma Ridge, a campus located in the heart of Northwest Austin's growth region. The office will welcome employees once construction is complete and it is safe for employees to return to an office work environment.

08:43 EDT Jaguar Health to sell $2.75M in Mytesi accounts receivable to Oasis Capital - Jaguar Health (JAGX) announced that Jaguar and its wholly owned subsidiary, Napo Pharmaceuticals have jointly entered into an accounts receivable purchase agreement with Oasis Capital pursuant to which Oasis has initially agreed to purchase all of the company's accounts receivable related to the April sales of the company's Mytesi drug product to Cardinal Health (CAH). The April accounts receivable have a gross value of $2.75M. Per the terms of the agreement, Oasis will receive a fee of 5.45% of the $2.75M April accounts receivable following their purchase of the April accounts receivable for $1.03M. Oasis will return to the company within five days any amount that exceeds the sum of the purchase price and the fee. As with all Mytesi gross sales, the April accounts receivable will be reduced by Medicare, ADAP 340B chargebacks, returns and wholesale distribution fees based on historical trends to determine net sales. Under the agreement, Oasis is entitled to a one-time transaction fee of $25,000 and may be entitled to additional transaction fees to the extent Oasis purchases additional accounts receivable under the agreement, which fees will not exceed $5,000 per transaction. The initial term of the agreement is one year, which will automatically renew for successive one-year periods unless notice of non-renewal is provided by the company at least 30 days prior to the expiration of a term. Notwithstanding the foregoing, either Oasis or the company may terminate the agreement on 60 days' prior written notice.

08:36 EDT Genasys receives $12.6M U.S. Army follow-on order - Genasys announced a $12.6M follow-on order from the U.S. Army for LRAD 450XL acoustic hailing devices, spares and accessories. This is the Company's third LRAD 450XL order received under the $110M Army AHD program. Another order is expected later this quarter.

08:35 EDT Appian announces technology partnership with DocuSign - Appian (APPN) announced a strategic technology partnership with DocuSign (DOCU) to extend the integration between DocuSign and Appian's low-code automation platform. DocuSign eSignature, part of the DocuSign Agreement Cloud, is available as a no-code plug-in to add market-leading electronic signature capabilities to any business process built on Appian. The DocuSign Connected System for Appian is available for all Appian customers running on version 19.4 or newer. Signatures are required for most high-value business processes, such as sales contracting, customer onboarding, licensing, and other legal agreements. The security of those documents and signatures is paramount. DocuSign meets some of the most stringent US, EU, and global security standards, and uses the strongest data encryption technologies available.

08:32 EDT China Xiangtai Food signs $8.5M soybean oil contract - China Xiangtai Food subsidiary Chongqing Ji Mao Cang Feed, or JMC, entered into an agreement to sell 10,000 tons of soybean oil to Chongqing Wave Trading by October. The contract is worth $8.5M and JMC has received a 20% deposit as advance payment. Acquired by the company in April, JMC specializes in the sale of feed raw material and supplying feed formula solutions. JMC has sold more than 200,000 tons of soybean meal in 2019.

08:29 EDT Sony sees FY21 consolidated operating income at least 30% lower y/y - Consolidated operating income for the fiscal year ending March 31, 2021 is currently estimated to be at least 30% lower than the level achieved in the previous fiscal year.

08:27 EDT Karyopharm donates 60,000 medical masks across Massachusetts, the U.S. - Karyopharm Therapeutics announced a new initiative to donate and distribute 60,000 medical masks to some of the most vulnerable individuals impacted by the ongoing COVID-19 pandemic including cancer patients, their families, and the healthcare workers caring for them. Karyopharm will donate masks to Family Reach, Myeloma Crowd and The Leukemia & Lymphoma Society, three prominent organizations focused on the well-being of cancer patients, to improve the safety and security of the broader cancer community. As part of this initiative, Family Reach, a national 501(c)(3) organization dedicated to eradicating the financial barriers that accompany a cancer diagnosis through their Financial Treatment Program, will distribute masks to hospitals throughout Massachusetts. Family Reach is addressing specific hospitals from across the state where the need is greatest. In addition, masks are being donated to Myeloma Crowd and The Leukemia & Lymphoma Society, both patient-driven, 501(c)(3) non-profit organizations that offer education and support services to patients with blood cancers, their family members and caregivers, throughout the U.S.

08:26 EDT NetSol Technologies 'confident' in ability to grow in FY21 - NETSOL President, Global Sales and Otoz CEO Naeem Ghauri added: "Traditionally, the fiscal fourth quarter is our strongest performance period, and we're currently tracking in this direction with a backloaded end of the year. We expect to see sequentially stronger revenues and EBITDA, allowing us to close out the year on an upward trajectory. With the global economic outlook still uncertain, we are seeing initial signs of recovery and activity picking up. Overall, we are confident in our ability to grow in fiscal 2021."

08:20 EDT ACM Research finalizes agreement to acquire land rights in Shanghai - ACM Research announced that its operating subsidiary ACM Research Shanghai, through a recently formed subsidiary, has entered into an agreement with the China Pilot Free Trade Zone Lingang Special Area Administration to acquire land use rights in the Lingang Heavy Equipment Industrial Zone of the Lingang Special Area of China Pilot Free Trade Zone. Under the agreement, ACM Shanghai plans to build a development and production facility approximately 30 miles from ACM Shanghai's headquarters in Zhangjiang.

08:18 EDT Cardiff Oncology partners with PoC Capital to fund Phase 2 mCRC trial - Cardiff Oncology announced an agreement with PoC Capital to fund the completion of its ongoing Phase 1b/2 clinical trial in patients with KRAS-mutated metastatic Colorectal Cancer. Cardiff's investigational drug, onvansertib, a first-in-class, third-generation Polo-like Kinase 1 inhibitor, is being evaluated in combination with standard-of-care chemotherapy and targeted therapeutics. Funding will enable the addition of new trial sites to accelerate completion of the Phase 2 clinical trial. Cardiff Oncology's agreement with PoC Capital follows positive safety and efficacy data from its Phase 1b trial. The data demonstrate clinical benefit in patients treated with onvansertib in combination with second line standard-of-care, FOLFIRI/Avastin. Seven out of eight evaluable patients achieved a clinical response and progression-free survival of 6.5 months, which exceeds the current standard-of-care response rate of 4% and median PFS of 5.5 months. Additional trial data will be presented as a virtual oral poster presentation at the American Society of Clinical Oncology annual meeting on Friday, May 29.

08:16 EDT GCP Applied Technologies urges shareholders to vote for director nominees - GCP Applied Technologies announced that it has mailed an open letter to shareholders in connection with its 2020 Annual Meeting of Stockholders, urging them to vote "FOR" ALL of GCP's director nominees on the BLUE Proxy Card at the 2020 Annual Meeting. The letter read, in part: " During these unprecedented times, the GCP Board and management team continue to focus on driving positive business momentum and delivering value for shareholders, while also ensuring the safety of our employees and customers. We ask that you reflect on the significant results our Board has delivered, the proactive steps the Board has taken to position the Company for sustained success and the Board's significant efforts to protect the interests of all shareholders from two dominant shareholders who seek to exert greater control over the Company...GCP's refreshed, experienced and independent Board has overseen the development of a clear strategy that is driving meaningful performance improvement...Under the leadership of CEO Randy Dearth, GCP has successfully executed against its stated strategy and delivered results...Our first quarter results demonstrate that the strong momentum overseen by this Board has continued into 2020. Our results significantly exceeded consensus estimates and represented our best first quarter earnings performance since 2016...Furthermore, our long-term focus on cost management and commitment to prudent capital management have made our strong balance sheet and liquidity position a true competitive differentiator in a challenging COVID-19 environment. A vote "FOR" all of GCP's director nominees on the BLUE proxy card or voting instruction form can help ensure our progress continues...GCP strongly believes replacing a supermajority of the Board would be highly disruptive and place at risk the Company's demonstrated business progress and momentum. Your current Board has the best interests of all shareholders in mind. Given that 40 North previously sought and received HSR approval to increase its ownership to nearly 50%, and that its affiliate is a natural acquirer of GCP, the actions taken by 40 North appear to be in its own self-serving interests, rather than the interests of all GCP shareholders. Similarly, Starboard's continued unwillingness to consider reasonable proposals for a consensual resolution on Board representation underscores Starboard's self-serving agenda at GCP. GCP's Board has been transparent and continuously seeks open engagement with, and ideas from, shareholders, including exhaustively trying to work with both Starboard and 40 North to settle this fight. Nonetheless, both Starboard and 40 North have insisted on replacing a supermajority of the Board. As such, we ask shareholders to consider whether they want to allow Starboard and 40 North to take creeping control of the Company. We strongly urge shareholders to vote the BLUE proxy card or voting instruction form and support ALL of GCP's refreshed, highly qualified, independent slate of director nominees. "

08:13 EDT NV5 Global announces $7M in essential infrastructure contract awards - NV5 Global has been awarded $7M in contracts to support infrastructure improvements in California. The newly awarded contracts will support critical infrastructure, including roadways, public works, and airport capital improvements and are considered essential services. In Merced County, NV5 secured a three-year, $2.5M contract to provide on-call surveying and engineering services for various state and federally-funded public works projects. An airport agency in Southern California also awarded NV5 a three-year, $2M contract to provide survey services associated with the airport's capital improvement program, airport design and construction, and major maintenance program. NV5 was selected for two bridge and roadway projects, totaling $2.5M. The first contract is a five-year contract funded by the State Transportation Improvement Program and Local Safety Seismic Bridge Retrofit Program to provide construction management, materials testing, source inspection, and special inspection services for the construction of two new bridges across the Sacramento River and its overflow area in Tehama County. NV5 was also awarded a one-year contract by the City of Bakersfield to provide construction observation, biological monitoring, contract administration, and project closeout services.

08:11 EDT Kratos Defense awarded $4.9M contract to update satellite ground system - Kratos Defense & Security Solutions announced that it had been awarded a $4.9 million contract to modernize the infrastructure and systems that interconnect the Air Force Satellite Control Network sites under the AFSCN Network Edge Transport System program. The ANETS system will enable the AFSCN to meet the growing needs of its user community.

08:09 EDT Lipocine's LPCN improves NASH, hepatic fibrosis features in pre-clinical study - Lipocine announced the results of a pre-clinical study of LPCN 1144, an oral prodrug of bioidentical testosterone. The pharmacological effect of LPCN 1144 was investigated in a non-genomic, five arm, 12-week high fat diet - HFD - -induced, rabbit animal model of NASH and hepatic fibrosis. In the pre-clinical study, the HFD induced histological NASH features with fibrosis, altered key biomarkers, and lowered serum testosterone levels. Histological and biomarker analyses also demonstrate that LPCN 1144 improved HFD-induced NASH features and hepatic fibrosis. LPCN 1144 treatment reduced HFD-induced visceral fat increase and insulin resistance. Lipocine plans to present the results at an upcoming scientific conference. LPCN 1144 is currently being studied in the LiFT Phase 2 paired biopsy clinical study in patients with confirmed non-cirrhotic NASH.

08:08 EDT XTO Energy extends offering period for Hugoton Royalty Trust acquisition - XTO Energy, a subsidiary of Exxon Mobil, announced that it has extended the offering period of its previously announced tender offer to purchase all outstanding units of beneficial interest in Hugoton Royalty Trust at a price of 20c per unit, net to the seller in cash, without interest and subject to any withholding of taxes. The tender offer is now scheduled to expire on Tuesday, May 26, unless the tender offer is further extended or earlier terminated in accordance with the terms set forth in the tender offer statement. The tender offer was extended to allow additional time, in light of the impacts of the COVID-19 pandemic, for unitholders to complete and return the transmittal documentation and to give instructions to their brokers. As of May 12, the last business day prior to the announcement of the extension of the tender offer, 6,772,120 units had been validly tendered and not withdrawn, representing approximately 16.9% of the outstanding units. Unitholders of the trust who have already tendered their Units do not need to re-tender their units or take any other action as a result of the extension of the expiration date of the tender offer. The tender offer is being made pursuant to the tender offer materials in the tender offer statement on schedule TO filed by XTO Energy with the United States Securities and Exchange Commission on April 1, as amended.

08:07 EDT Duos Technologies Group awarded exclusive contract by Monroe County Sheriff - Duos Technologies Group, through its operating subsidiary Duos Technologies, has been awarded a new major contract to provide the company's intelligent control solution for the Monroe County, Florida Sheriff's office. The project is valued at approximately $945,000. The new system will be installed into the new Plantation Key Courthouse and Detention Center, currently under construction and located in Monroe County, FL. This solution is based upon the current Duos system deployed at Monroe County's primary detention facility located in Key West, FL.

08:05 EDT Alector to initiate Phase 2 trial of AL002 in 2020 - Following the completion of the Phase 1a study with AL002 and based on the safety and biomarker data collected in preclinical studies and in healthy volunteers, and in agreement with its partner AbbVie, Alector has closed enrollment for the Phase 1b study of AL002 and will proceed with initiating a Phase 2 trial in Alzheimer's disease patients in 2020. The Company continues to advance the Phase 1b trial of AL003 in Alzheimer's disease. AL003 is being developed by Alector in collaboration with its partner AbbVie. Alector plans to initiate Phase 1 development for AL014 within the next 12 months. AL014 is the Company's latest prioritized candidate that targets MS4A4A, a transmembrane receptor protein that is expressed selectively in microglia in the brain and is associated with control of microglia functionality and potential viability.

08:03 EDT Alector expects cash to fund operations through 2022

08:03 EDT Alector continuing efforts to complete enrollment across trials - The company said, "Alector is actively monitoring the evolving impact of COVID-19 on its operations and clinical trials, with a primary focus on the health and safety of employees, clinical trial participants, and clinical trial site teams. The Company is complying with regulatory, institutional, and governmental guidance for conducting its business worldwide. As the COVID-19 pandemic continues to evolve, it could impact Alector's programs in the future. The Company is also continuing with its efforts to complete enrollment across ongoing clinical trials. Currently, certain clinical trial sites have delayed enrollment of new patients and paused clinical trial visits across clinical development programs. Alector is aware that some participants in ongoing trials have not been able to receive scheduled doses on time due to site closures or various state and local shelter-in-place directives. However, the Company is continuing to collect data from all existing clinical trial participants enrolled to date. The Company remains on track with previously stated guidance to initiate a pivotal Phase 3 study of AL001 in FTD-GRN patients in 2020. Alector also intends to initiate a Phase 2 study of AL002 in Alzheimer's disease patients in 2020. Ongoing activities for AL003, AL101, and AL014 programs are continuing as planned."

07:47 EDT Thermo Fisher to develop antibodies test with WuXi Diagnostics, Mayo Clinic - Thermo Fisher announced it will expand its response to the COVID-19 pandemic by developing a total antibodies test in collaboration with WuXi Diagnostics and Mayo Clinic. The new test is the result of ongoing collaboration between all three organizations, including clinical evaluation and support from Mayo Clinic. Thermo Fisher will seek U.S. FDA Emergency Use Authorization and international regulatory authorizations for the test over the next few weeks.Once approved for use, the Thermo Scientific OmniPath COVID-19 Total Antibody ELISA test will detect Immunoglobulin M and Immunoglobulin G to help clinicians determine if a patient has been exposed to SARS-CoV-2. The test is designed to run on an open instrument platform, and the determination of antibody status will aid in the diagnosis of the disease during the acute and recovery stages of infection.

07:40 EDT Navios Maritime Partners expects liquidation of Navios Europe II in Q2 - On April 21, 2020, Navios Europe II agreed with the lender to fully release the liabilities under the junior participating loan facility for $5.0 million. Navios Europe II owns seven container vessels and seven dry bulk vessels. The structure is expected to be liquidated during the second quarter of 2020 and Navios Partners expects to receive cash and steel value. The Company's Conflict Committee will consider and approve the liquidation.

07:29 EDT Alio Gold, Argonaut Gold remind shareholders to vote on merger - Argonaut Gold and Alio Gold would like to remind shareholders and certain securityholders that they have until 11:30 a.m. Eastern time on Friday May 15, 2020 to vote their shares or securities by proxy at the companies' respective upcoming Annual and Special Meetings. Each of the Argonaut Gold and Alio Gold Board of Directors has unanimously recommended that the shareholders and certain securityholders of their respective companies vote FOR each of the proposed resolutions to be considered at their respective Annual and Special Meetings. In addition, both Institutional Shareholder Services and Glass, Lewis & Co., two leading independent third party proxy advisory firms, have issued positive reviews of the proposed merger of Argonaut and Alio, and both recommend that shareholders vote in favour of the resolutions to be voted upon at the Annual and Special Meetings of Argonaut Gold and Alio Gold to be held on May 20, 2020. Argonaut and Alio shareholders of record at the close of business on March 30, 2020 and April 14, 2020, respectively, are eligible to vote their common shares and registered holders of options, RSUs, PSUs and DSUs of Alio at the close of business on April 14, 2020 are eligible to vote those securities on the resolution to approve the Argonaut Gold and Alio Gold merger.

07:23 EDT Capricor Therapeutics announces top-line results from HOPE-2 study - Capricor Therapeutics announced positive top-line 12-month results of the HOPE-2 clinical trial using CAP-1002 to treat patients in advanced stages of Duchenne muscular dystrophy, a genetic disorder characterized by progressive weakness and chronic inflammation of the skeletal, heart, and respiratory muscles. Boys and young men typically lose their ability to walk in their teens and generally die of cardiac or respiratory complications by the 3rd decade of life. The data showed improvements in upper limb, cardiac and respiratory function with p-values less than p=0.05 in multiple measures. The 12-month data from HOPE-2 showed statistically meaningful improvements in the PUL 2.0 in CAP-1002 treated patients with a mean change of 2.4 points over placebo patients. With the exception of steroids, preservation of function in DMD is uncommon. The placebo patients declined consistent with natural history, but in the treated group, most patients were stable or improved throughout the one-year treatment period. The performance of the upper limb is a clinically validated measure that evaluates upper limb strength in patients who are generally non-ambulant. Retention of upper limb function is important for self-care and preservation of human dignity and has become a focus for physicians and advocates to find treatments to help these later stage patients. The FDA has suggested the use of the updated PUL 2.0 version as the primary efficacy endpoint in support of a Biologics License Application. The data also showed global improvements in cardiac function as measured by ejection fraction (p=0.004) and indexed volumes. These are surrogate measures of cardiac function and are considered the "gold standard" in terms of relevance to long term outcomes. Remarkably, there is also a reduction in the biomarker CK-MB, an enzyme that is only released when there is cardiac muscle cell damage. In normal human subjects, there is typically no CK-MB measurable in the blood. It is well accepted that continuous muscle cell damage in DMD leads to pathologically high enzyme levels associated with cardiac muscle cell loss. HOPE-2 demonstrated a reduction in CK-MB levels as compared to placebo. This is the first ever study in DMD that correlates cardiac functional stabilization with reduction of a biomarker of cell damage. CAP-1002 was generally safe and well tolerated throughout the study. With the exception of hypersensitivity reactions which were mitigated with a common pre-medication regimen, no safety signals were identified in the HOPE-2 trial. The FDA has granted Capricor's CAP-1002 RMAT and Orphan Drug Designation, and the FDA has also granted a Rare Pediatric Disease Designation to CAP-1002 for DMD. The Rare Pediatric Disease Designation, as well as the Orphan Drug Designation previously granted, covers the broad treatment of DMD. If Capricor were to receive market approval for CAP-1002 by the FDA, Capricor would be eligible to receive a Priority Review Voucher. This is the second clinical trial investigating CAP-1002 showing similar results in DMD. Capricor completed the HOPE-Duchenne trial published in Neurology, the medical journal of the American Academy of Neurology in 2019. The Company has initiated a technology transfer with a leading global CMO to prepare for commercial manufacturing of CAP-1002.

07:18 EDT Avrobio announces new Fabry disease, cystinosis program data at ASGCT - Avrobio announced new clinical data from its investigational programs for Fabry disease and cystinosis. The data will be presented at the American Society of Gene & Cell Therapy, or ASGCT. Four patients have been dosed in the Phase 2 trial of AVR-RD-01, Avrobio's investigational lentiviral gene therapy for Fabry disease. The first patient continued to show increased leukocyte and plasma AGA enzyme activity, now up to 22 months post-treatment. These data suggest the patient is producing an endogenous supply of functional alpha-galactosidase, or AGA, enzyme, which is essential to prevent the accumulation of a toxic metabolite, lyso-Gb3, in tissues including the heart and kidneys. A sustained decrease in plasma lyso-Gb3 and total Gb3 levels has previously been reported for this patient out to 18 months. The third patient had a sustained decrease in plasma lyso-Gb3 and total Gb3 levels nine months after dosing. This patient also had a stable vector copy number, or VCN, out approximately one year post-treatment, suggesting successful engraftment. The fourth patient, who is also the first to be dosed with Avrobio's plato gene therapy platform, had a 43% reduction in the toxic metabolite plasma lyso-Gb3 at one month. At three months, he also had leukocyte enzyme and plasma enzyme activity levels approximately three times higher than the mean activity level of the first three patients in the same trial at the same timepoint. While the presentation will focus on data updates for its Phase 2 trial, the company also reports that all three Phase 1 patients who discontinued enzyme replacement therapy, or ERT, after receiving AVR-RD-01 gene therapy, remain off ERT as of April 27. As of the safety data cut-off date of November 26, 2019, there have been no safety events attributed to AVR-RD-01 drug product in either the Phase 1 or Phase 2 trial. Through the safety data cut-off date, four serious adverse events, or SAEs, have been reported in the FAB-201 trial and two SAEs in the Phase 1 trial. The fourth Phase 2 patient, who was dosed after the safety data cut-off date, has reported an SAE, which was not attributed to AVR-RD-01 and which subsequently resolved. Across both studies, each of the SAEs has been consistent with the conditioning regimen, stem cell mobilization, underlying disease or pre-existing conditions. Pre-existing low anti-AGA antibody titers have been detected in four patients in the Phase 1 trial and a transient low titer was observed but not detectable in subsequent measures in one patient in the Phase 2 trial. Avrobio continues to actively identify participants for the Phase 2 Fabry disease trial in Australia, Canada and the U.S. The FAB-201 trial is an ongoing open-label, single-arm Phase 2 clinical trial evaluating the efficacy and safety of AVR-RD-01 in eight to 12 treatment-naive Fabry disease patients. New data will also be presented from the first patient dosed in the investigator-sponsored Phase 1/2 trial of AVR-RD-04 for cystinosis, a progressive disease marked by the accumulation of cystine in cellular organelles known as lysosomes. This buildup can cause debilitating symptoms including kidney failure, corneal damage and thyroid dysfunction, often leading to a shortened lifespan. Currently, more than 90% of treated cystinosis patients require a kidney transplant in the second or third decade of life. The current standard of care for cystinosis is cysteamine, a burdensome treatment regimen that can require dozens of pills per day and may not prevent overall progression of the disease. Six months following administration of AVR-RD-04, the patient's estimated glomerular filtration rate, which is a measure of kidney function, improved from 38 mL/mi/1.73m2 at baseline to 52 mL/mi/1.73m2. The patient's serum creatinine, another measure of kidney function, also improved, falling from 2.2 mg/dL at baseline to 1.6 mg/dL at six months. The patient stopped cysteamine treatment before administration of AVR-RD-04 and remains off cysteamine. As of the safety data cut-off date of January 27, which was approximately three months following administration of the investigational gene therapy to the first patient in the AVR-RD-04 program, there have been no reports of safety events attributed to the investigational drug product. In addition, no SAEs have been reported as of the safety data cut-off date. Adverse events did not suggest any unexpected safety signals or trends.

07:12 EDT Bluebird sinks after FDA issues Refusal to File letter for myeloma treatment - Bristol Myers Squibb (BMY) and Bluebird Bio (BLUE) announced this morning that the companies received a Refusal to File letter from the FDA regarding the Biologics License Application for idecabtagene vicleucel for patients with heavily pre-treated relapsed and refractory multiple myeloma, which was submitted in March 2020. Upon preliminary review, the FDA determined that the Chemistry, Manufacturing and Control module of the BLA requires further detail to complete the review. the companies said in a statement. No additional clinical or non-clinical data have been requested or are required. Bristol Myers Squibb is planning to resubmit the BLA no later than the end of July 2020. Shares of Bluebird Bio are down 9% to $51.97 in premarket trading while Bristol-Myers is down 43c to $62.92.

07:10 EDT Caleres begins phased reopening of stores - Caleres announced it has begun a phased reopening of its Famous Footwear, Allen Edmonds, Naturalizer and Sam Edelman retail stores in a safe and systematic manner. Recently, Caleres began to reopen retail stores in areas where restrictions have been relaxed or lifted. The company will progress with this approach over the next several weeks, and currently expects to have approximately 435 locations open by the end of May. Caleres is closely monitoring state and local restrictions and guidelines as it moves forward with the resumption of in-store operations across its entire store fleet. Caleres anticipates the vast majority of its stores to restart in-store service by the end of June. Caleres' top priority is the health and safety of its associates and its customers, and the company is taking numerous steps and following government guidelines to ensure a safe and comfortable in-store experience for all parties. Caleres is customizing its stores to ensure appropriate distancing and contactless transactions; equipping its Associates to provide the most health-conscious service and intensifying its rigorous cleaning and sanitizing procedures. During the recent period of store closures, Caleres leveraged its brand power and the upfront investments made in its e-commerce platform to shift to a digital-only business. Since that time, Caleres has consistently explored ways to reach its consumers and meet their needs. In recent weeks, the company has implemented a contactless curbside pickup option at approximately 170 locations across the country, with the expectation that this service will be expanded to reach nearly 300 stores by next week. This additional service channel provides an important supplement to the strong e-commerce-related sales the company has experienced, particularly at Famous Footwear. Caleres has focused on managing costs, reducing capital expenditures, driving down inventory levels and boosting liquidity and has maintained a stable cash position since the store closures in mid-March. The company expects that the gradual add back of its brick-and-mortar operations, coupled with strength in its e-commerce-related business establishes a viable path to positive cash generation in the year's second half.

07:08 EDT Fulcrum Therapeutics on track to initiate Phase 1 trial of FTX-6058 in 2H20

07:06 EDT Fulcrum Therapeutics expects cash to fund requirements into 3Q21 - As of March 31, 2020, cash, cash equivalents, and marketable securities were $81.2 million, as compared to $96.7 million as of December 31, 2019. Based on its current plans, the Company expects that its existing cash, cash equivalents and marketable securities will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the third quarter of 2021.

07:04 EDT Applied Genetic expects additional data from Phase 1/2 program in ACHM in 2H20 - In January, AGTC announced encouraging interim data from the dose-escalation cohorts of its ongoing Phase 1/2 clinical programs in patients with ACHM due to mutations in the ACHM CNGB3 or ACHM CNGA3 genes. The interim three-month results from both studies demonstrated encouraging signs of biologic activity based on improvements in light discomfort. Interim six-month data from both trials continue to demonstrate a favorable safety profile with no dose-limiting inflammatory responses. In March, AGTC completed the planned enrollment in all dose groups for adult patients, including the two higher dose groups, of both ACHM trials, bringing the total number of adults dosed to 15 in the ACHM A3 trial and 22 in the ACHM B3 trial. Pediatric dosing is ongoing with three pediatric patients dosed in each trial to date. The company expects that pediatric enrollment will continue to be challenging. The company plans to release additional data for the adult dose groups in the second half of 2020, which will be used to inform decision-making regarding readiness to move the product candidates to pivotal trials.

07:03 EDT Vanda Pharmaceuticals to resubmit application to FDA for HETLIOZ - Vanda Pharmaceuticals announced that following the completion of a Type A Meeting with the U.S. FDA on May 8, it has reached agreement with the FDA to resubmit its application for HETLIOZ for the treatment of Smith-Magenis Syndrome. As previously disclosed, Vanda received a Refusal to File letter from the FDA on March 12. The Type A Meeting resolved the outstanding issues regarding the filing of the application. Vanda plans to resubmit as soon as possible, seeking approval of the solid capsule formulation of HETLIOZ for the treatment of adults with SMS, and the liquid formulation of HETLIOZ for the treatment of children with SMS.

07:01 EDT Bristol-Myers, Bluebird Bio receive RTF letter on BLA for idecabtagene vicleucel - Bristol Myers Squibb (BMY) and bluebird bio (BLUE) announced that the companies received a Refusal to File letter from the U.S. FDA regarding the Biologics License Application for idecabtagene vicleucel for patients with heavily pre-treated relapsed and refractory multiple myeloma, which was submitted in March 2020. Upon preliminary review, the FDA determined that the Chemistry, Manufacturing and Control module of the BLA requires further detail to complete the review. No additional clinical or non-clinical data have been requested or are required. Bristol Myers Squibb is planning to resubmit the BLA no later than the end of July.

06:36 EDT Maximus and Genesys partner in cloud-based platform for government agencies - Maximus entered an agreement with Genesys to offer the Maximus Genesys Engagement Platform, an integrated, cloud-based omnichannel contact center solution. for federal, state and local agencies to adhere to government mandates. Federal mandates require government agencies to attempt to provide seamless customer experiences similar to those offered in the private sector and help improve the citizen experience. The solution provides the ability to integrate calls, emails, chats, messages and social comments into one uninterrupted conversation

06:19 EDT Simon & Schuster CEO Carolyn Reidy dies following heart attack - Carolyn Reidy, the CEO of book publisher Simon & Schuster, a unit of ViacomCBS, died Tuesday morning after suffering a heart attack, the company said in a statement. CFO Dennis Eulau said "Carolyn was both an exemplary leader and a supremely talented and visionary publishing executive. Since joining Simon & Schuster in 1992 as President of the Trade Division, she has been a vital and energetic force within our company, leading us to unprecedented growth on both the domestic and international fronts, and steering us through the transition to publishing in the digital era." Reference Link

06:09 EDT Mesoblast completes financing to scale-up manufacturing of remestemcel-L - Mesoblast announced that it has successfully completed a capital raising of $90M via a private placement of 43M shares to existing and new institutional investors at a price of A$3.20 per share. This represents a 7% discount to both the price at the close of trading May 8 and the five-day volume weighted average price. A significant portion of the net proceeds will be used to scale-up manufacturing of the company's lead product candidate remestemcel-L for the treatment of critically ill patients suffering with diseases caused by cytokine release syndromes associated with high mortality, particularly COVID-19 acute respiratory distress syndrome. Proceeds will also be used for working capital and general corporate purposes. A randomized controlled Phase 2/3 trial in up to 300 patients evaluating whether remestemcel-L can reduce the high mortality in COVID-19 patients with moderate/severe ARDS is actively enrolling in up to 30 sites in the United States. This trial was initiated after promising results were seen with remestemcel-L under emergency compassionate use in COVID-19 ARDS, where 9 of 12 ventilator-dependent patients were able to come off ventilators within a median of 10 days.

06:07 EDT CytoDyn completes all remaining parts of BLA for leronlimab - CytoDyn confirmed on May 11, it submitted all remaining parts of the company's Biologics License Application for leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients to the U.S. FDA. Pursuant to FDA guidelines, CytoDyn informed the FDA it had submitted a complete BLA for rolling review. As a next step, the FDA will start reviewing the BLA for completeness and will make a filing decision. After the BLA submission is deemed completed, the FDA assigns a Prescription Drug User Fee Act goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA, and the company plans to request a priority review for the BLA. A priority review designation, if granted, means the FDA's goal is to take action on the application within six months of receipt.

06:04 EDT Alphabet's Loon, Vodacom partner to increase rural internet access in Mozambique - Alphabet's (GOOG, GOOGL) Loon and Vodacom (VDMCY) have signed a deal to use Loon's balloon-powered internet solution to expand the Vodacom network in Mozambique. In terms of the agreement, Loon will help Vodacom provide service to un-served and under-served parts of the country with a network of floating cell phone towers that operate 20 kilometres above Earth. Using the Loon solution, Vodacom will expand mobile network access to Cabo Delgado and Niassa provinces, two regions that have proven hard to cover in the past due to the vast and logistically challenging geographical areas, together with low population density. The Loon solution will provide a 4G service that supports Data, Voice, SMS and USSD, which will also enable mobile financial services. The service will be available to any Vodacom subscriber with a standard 4G-VoLTE enabled handset and SIM card. Users will not need to do anything special to connect to the service; they will connect just as they would to a normal cell tower. In fact, it's unlikely that a user will know that they are connected to the service provided by a high altitude balloon, except for the fact that they may have a signal in a location where it previously did not exist.

05:23 EDT Synnex enters distribution agreement with Bitdefender - Bitdefender announced that it has entered into a distribution agreement with Synnex. Bitdefender's Cloud Security for MSPs will be offered via the Synnex Stellr Marketplace in 2020. "The agreement allows Bitdefender and Synnex to offer a more complete portfolio of solutions to reseller, CSP and MSP partners. Partners are, in turn, able to add value for their customers by simultaneously simplifying the buying and deployment journey and offering leading solutions that integrate seamlessly while strengthening business processes and security posture."

05:18 EDT Merck Animal Health to acquire U.S. rights to SENTINEL brands from Virbac - Merck Animal Health, a division of Merck, and Virbac announced that the companies have signed a definitive agreement under which Merck Animal Health would acquire the U.S. rights to SENTINEL FLAVOR TABS and SENTINEL SPECTRUM Chews in the Companion Animal category. Merck Animal Health will make a cash payment of approximately $400M to acquire the SENTINEL branded products in the United States at closing of the acquisition. The closing of the transaction is subject to antitrust clearance and other customary closing conditions and is expected to close by mid-year 2020.